Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012)

MCM Vaccines B.V.754 enrolled

Overview

This is a multicenter extension study of two European randomized, double-blind studies (V419-007 and V419-008). It describes long-term persistence of hepatitis B and pertussis antibody responses in healthy 4- to 5 year old children previously vaccinated with Vaxelis® or INFANRIX® hexa

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

754

Conditions

Hepatitis B Pertussis

Interventions

Blood SampleOTHER

Blood sample at approx. 4 years of age

Eligibility

Sex: ALLMin age: 3 YearsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria 1. Healthy child of either gender, who has received a complete 3-dose primary series or a complete 2 dose primary series followed by a toddler dose with VAXELIS or INFANRIX hexa as part of the V419-007 or V419-008 study respectively. 2. Informed consent signed by the participant's parent(s) or legal representative. Exclusion Criteria: 1. Participant who has received any dose of hepatitis B (HB)-containing vaccine at any time other than study vaccine in V419-007 or V419-008 study. 2. Participant with a history of diagnosis (clinical, serological or microbiological) of HB virus infection of the V419-007 or V419-008 study. 3. Participant who has received any dose of pertussis-containing vaccine after completion of the V419-008 study. 4. Participant with a history of diagnosis (clinical, serological or microbiological) of infection due to pertussis after completion of V419-008 study. 5. Participation at the time of study enrolment or in the 4 weeks preceding the study enrolment in another clinical study investigating a vaccine, drug medical device, or medical procedure\*. 6. Participant who received immunoglobulins, blood or blood-derived products within 3 months prior to inclusion\*. 7. Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy since completion of V419-007 or V419-008 studies. 8. Participant with suspected or known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopietic and lymphatic systems since completion of V419-007 or V419-008 studies. * Criteria 5 and 6 are temporary exclusion criteria. If a participant meets criteria 5 and/or 6 at the time of Visit 1, a further appointment is to be scheduled to reassess the participant's eligibility.

Outcomes

Primary Outcomes

Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg)

Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. Response was defined as a titer \>=10 milli International units (mIU)/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.

Time frame: Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)

Percentage of Participants Responding to Pertussis Toxin

Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. The unit of measure is ELISA units/mL. The lower limit of quantification (LLOQ)=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.

Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)

Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. LLOQ=3 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.

Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)

Percentage of Participants Responding to Pertussis Pertactin

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.

Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)

Percentage of Participants Responding to Pertussis Fimbriae

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.

Data from ClinicalTrials.gov

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Secondary Outcomes

Geometric Mean Concentration of Antibodies to HBsAg

Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. The unit of measure is milli International Units/mL (mIU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.

Time frame: Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)

Geometric Mean Concentration of Antibodies to Pertussis Toxin

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.

Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)

Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.

Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)

Geometric Mean Concentration of Antibodies to Pertussis Pertactin

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.

Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)

Geometric Mean Concentration of Antibodies to Pertussis Fimbriae

Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.

Time frame: Day 1 (approximately 4 years after completion of the 2+1 schedule)